Legislation
The Over the Counter Hearing Aid Act of 2017 was passed as part of the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017 (FDAR). This law requires the Food and Drug Administration (FDA) to propose a rule that would establish an OTC hearing aid category for adults with “perceived” mild-to-moderate hearing loss within 3 years of passage of the legislation and finalize a rule within 180 days after the close of the comment period. The provisions of the OTC Hearing Aid Act implement major recommendations from the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NASEM).
Consensus Document
In 2018, The Academy also teamed up with other members of the hearing health community to draft consensus recommendations for this new class of devices. The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.
Regulations
The FDA released the proposed rule for regulation of OTC hearing aids on October 20, 2021.
The FDA provides 90 days for public comment with a deadline of 1/18/2022. Individuals can submit comments, in addition to organizations and other entities. The link to submit the comments and to access other submitted comments is available with the proposed rule.
The Academy formed a subject matter expert work group of members to analyze the proposed rule and prepare draft comments. The Academy board reviewed and approved final comments, and the Academy submitted the comments to the FDA on December 8, 2021. The FDA has to review and respond to all received comments, so the final rule likely will not be out before late spring.
Over-the-Counter Hearing Aids FAQs for Audiologists
Basic Definitions
Over-the-counter (OTC) hearing aids are devices that amplify sound and can be purchased without a professional fitting and without a hearing test. OTC hearing aids are approved for adults 18 years of age and older with mild-to-moderate hearing loss.
Direct-to-consumer devices are currently available as instruments that can be purchased by the consumer with access to remote support. OTC hearing aids are similar to direct-to-consumer devices in that consumers independently decide if they need the device and select what device(s) to purchase. The consumers handle the device setup, including the physical fit of the device and tuning of the sound, without professional support. Although not required, any consumer can get a hearing test before buying OTC hearing aids to benefit from the advice of an audiologist regarding whether they are a candidate for an OTC hearing aid.
Audiologists also can provide support in the use of OTC hearing aids for an office visit charge (typically not covered by insurance).
OTC hearing aids are meant to be less expensive than professionally fitted hearing aids. The lower cost for OTC hearing aids is due to technology differences and because no professional services or fees are associated with the purchase (the individual is self-selecting and self-fitting).
No. The comment period has closed, and the US Food and Drug Administration (FDA) is now reviewing submitted comments. The FDA received 937 comments by the deadline from consumers, professional organizations, industry, federal agencies, and other stakeholders. We expect to see the final rule before the end of 2022.
Strictly speaking, OTC hearing aids are not available yet because the FDA rule is not formalized. The Academy’s e-learning platform, www.eaudiology.org, will be providing continuing education as the FDA final rule is published and as we see OTC hearing aids come into the marketplace.
The FDA Reauthorization Act of 2017 includes language that directed the FDA to create a class of OTC hearing aids in response to demands of consumers and other government agencies to increase the affordability and accessibility of hearing aids in the United States.
The FDA is in the process of finalizing the regulations that will surround this new class of amplification devices. These rules will include (1) how loud these devices can be, (2) what labeling will be required on the outside and inside of the box that these devices come in, and (3) requirements related to the sale of these devices.
OTC hearing aids are approved only for use by adults 18 years of age and older who have mild-to-moderate hearing loss. Ideally, an individual will receive a hearing test from an audiologist to determine their level of hearing loss so they will know whether they are a candidate for this type of hearing aid. However, a hearing test is not required, and an individual with perceived mild-to-moderate hearing loss may purchase OTC hearing aids directly.
Although an individual cannot accurately determine whether they have hearing loss, the type or degree of hearing loss if present, or the potential cause of hearing difficulties without professional evaluation, there are some behavioral indicators that may suggest the individual could benefit from hearing assistance. If the individual does not want to get a hearing test, they may consider the following questions as they try to determine whether they have a mild-to-moderate hearing loss and/or whether they should consider an OTC hearing aid:
- Are they able to hear easily in quiet, one-on-one situations but experience difficulty in more challenging listening conditions?
- Are there a few difficult listening situations where they think they would want to wear the OTC hearing aid as opposed to feeling like they would need it in most communication situations?
- Does turning up the volume on the phone or TV just slightly help them hear better (this level might be considered a little loud by others but not extremely loud as opposed to needing to turn these devices up quite a bit to a level that bothers others)?
If the individual answered yes to these questions, they may have mild-to-moderate hearing loss. If the individual experiences more significant hearing and/or communication challenges in several environments, they may have more than a mild-to-moderate hearing loss and may not benefit from an OTC device. People with moderately severe-to-severe hearing loss will have difficulty in these situations as well, but they will have difficulty more consistently across many situations as identified by themselves or by those around them.
Although the OTC regulations have not been released, it is expected that OTC hearing aids will require that the user will be able to follow instructions to fit the device to their ear and to tune the sound of the device. This could include an automated hearing test that requires responses to sounds, as well as manipulating a volume control or an app-based program that has the user change the bass and treble to find a sound combination that is perceived to be helpful.
No. OTC hearing aids are approved only for individuals 18 years of age and older. Due to the medical nature of childhood hearing loss and the importance of accurate sound delivery for the developing brain, OTC hearing aids are not appropriate for children. Learn more by visiting Children and Over-the-Counter Hearing Aids.
You, as an audiologist, serve as a vital member of a health-care team in treating children with hearing loss to ensure the best outcomes.
Once the FDA regulations are finalized, OTC hearing aids will likely be advertised and sold in local drug stores, big-box stores, online, via mail, and even in an audiologist’s office.
This information is not yet available. Manufacturers and distributors will set the price of any device.
Incorporating Over-the-Counter Hearing Aids Into Your Audiology Practices
Audiologists may choose not to provide OTC devices. However, many may choose to offer OTC devices directly or to provide professional support services to individuals who have purchased OTC devices elsewhere. OTC hearing aids can be incorporated into your clinical practice as an additional amplification option for patients with mild-to-moderate hearing loss. Your role with OTC hearing aids would be to ensure that the fit and “programming” of the OTC hearing aid is appropriate and optimal, within the limits of the technology, and to educate and guide the patient relative to appropriate expectations and care/use of the instrument.
One advantage of this model is that if an OTC hearing aid does not meet a patient’s communication needs, or is no longer appropriate for a patient, you can recommend an amplification option that is more appropriate. This would be part of a continuum of care focused on a patient-centered hearing treatment plan. Each practice will need to determine what role the audiologist plays in this activity and/or what role is appropriate for an audiology assistant. These decisions would be made in the context of the state laws under which the audiologist practices.
Alternatively, you may choose not to dispense OTC hearing aids but still elect to support patients who have purchased OTC hearing aids and are looking for assistance. Again, each practice will have to consider if this support is provided by an audiologist or an audiology assistant. The patient should be made aware of the fees associated with these services.
Members of the American Academy of Audiology can access a variety of recommendations and resources to aid in learning more about this process:
- Navigating Your Practice Now that Mainstream Over-the-Counter Hearing Aids Are Coming
- Embracing Change in Audiological Treatment: Over-the-Counter Hearing Devices
- Position Statement: The Role of Audiologists with Over-the-Counter Hearing Aids
- The Audiologist’s Guide to Hearing Aids, Personal Sound Amplification Products, Hearables, and Over-the-Counter Devices
Any services that are part of a comprehensive hearing habilitation plan to enhance performance and outcomes with traditional (prescriptive) amplification options may be of benefit to the OTC hearing aid user.
Depending on need, you may offer the following:
- Diagnostic evaluation to confirm candidacy or to obtain necessary data to improve setting and selection of adjustable features, as available
- Adjustment of settings and features, if available on the device, with real-ear measurement to verify the impact of the device settings on access to the speech spectrum
- In-office cleaning and repair as well as guidance on the use and care of the device; electroacoustic analysis may be necessary to confirm the functionality and quality of sound
- Supportive counseling
You will want to consider the level of expertise needed to assist individuals with OTC hearing aids. The patient may see you, the audiologist, for diagnostic evaluation, but an assistant may be able to support the OTC hearing aid fitting (e.g., instruction in insertion, removal, and care).
If a patient who already owns an OTC hearing aid schedules to come in for assistance, they may be scheduled with an audiology assistant. Depending on the patient’s needs, the assistant may resolve the issue or the assistant may determine that the patient needs a hearing evaluation or measurement of the output of the devices. These services would be provided by you, the audiologist.
Professional fees should apply for services provided to support OTC hearing aid use. The Academy’s Guide to Itemizing Your Professional Services (May 12, 2022) is a good resource for practices that are not already unbundling services and products.
Update your practice website with information about OTC hearing aids. This should include information about whether the practice will sell OTC hearing aids and/or offer services to patients who have purchased them elsewhere. We encourage you to link your site or communications to the Consumers and OTC Hearing Aids section of the Academy site.
Review the pricing/payment structure relative to OTC hearing aids and professional services, as well as the protocol within the office for evaluating patients for OTC hearing aids. For example, will the practice recommend a hearing evaluation? Who will see patients with OTC hearing aids (the audiologist or assistant)?
If you decide to engage in treatment that includes OTC devices, you will want to review your billing practices and ensure you have unbundled options for charging for services that support improved outcomes with device fitting, as discussed in The Audiologist’s Guide to Hearing Aids, Personal Sound Amplification Products, Hearables, and Over-the-Counter Devices.
In a recent study that mimicked the direct-to-consumer model, many individuals still required assistance in the selection and use of the devices.1 Offering and supporting OTC hearing aids with professional services allows you, the audiologist, to demonstrate the benefits of audiologists as hearing-health-care professionals, set realistic expectations with the consumer about what to expect from OTC hearing aids, and establish rapport with patients such that if OTC hearing aids are not successful or no longer an appropriate option, the patient can proceed with prescriptive devices and rehabilitative services as needed.
Reference
1Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The effects of service-delivery model and purchase price on hearing-aid outcomes in older adults: A randomized double-blind placebo-controlled clinical trial. Am J Audiol 2017;26(1):53–79.
Check out the Academy's Guide to Itemizing Your Professional Services (May 12, 2022).
The FDA rules are not finalized yet, so technically there are no OTC hearing aids on the market at this time. Once there are OTC hearing aids, you will want to gather information on different options to decide what might work in your practice.
The Academy will be looking for reports on the response and sound quality of these devices as they come out and reports related to ease of use by consumers. Remember, you are equipped to measure the output of any device that makes sound by using your electroacoustic analysis or real-ear probe microphone measurements to inform yourself regarding the capabilities of these devices.
We would expect there to be online reviews once OTC hearing aids are available that will be helpful as these products are used by others and they report on their experience.
You may want to consider providing this type of information on your website in case a patient lands on your page searching for OTC hearing aid advice:
If your hearing loss is greater than mild to moderate or you have any of the symptoms listed below, you should not purchase an OTC hearing aid without first seeing an audiologist or ear, nose, and throat (ENT) physician:
- Malformed or misshapen ear at birth or due to trauma
- History of drainage from the ear within the previous 90 days
- History of sudden or rapidly progressive hearing loss within the previous 90 days
- Dizziness that you have just experienced or that you have experienced over a long time
- Hearing loss in only one ear or sudden or recent onset of hearing loss within the previous 90 days
- Significant ear wax accumulation or a foreign body in the ear canal
- Pain or discomfort in the ear
You should also seek medical advice if any of these symptoms occur after using an OTC hearing aid.
Studies show that the average person waits for approximately seven years1 after the onset of symptoms before seeking professional hearing help. An increasing number of studies are also confirming that untreated hearing loss is associated with poor health outcomes, including an increased risk of depression,2 falls,3–4 and earlier onset of cognitive decline.5–6 One goal of OTC hearing aids is to provide better access to lower-cost hearing aids, which might be pursued sooner by some individuals.
Although OTC hearing aids may be a good first step in getting people situational hearing help earlier, when an individual needs a more customized solution, or when the degree of hearing loss increases, an audiologist should be involved to create a comprehensive plan of care.
You may want to consider offering OTC hearing aids as part of your practice to connect the individual to your practice sooner rather than later. Alternatively, you may want to provide information on your website and the opportunity to be seen in your clinic if an individual needs support with an OTC hearing aid that they have already purchased. Again, this is one way to connect individuals to your practice. You want to be identified as the source of trusted information in all things related to hearing health and hearing assistance.
References
1Kochkin S. MarkeTrak VIII: 25-year trends in the hearing health market. Hearing Rev 2009;16(11):12–31.
2Golub JS, Brewster KK, Brickman AM, et al. Association of audiometric age-related hearing loss with depressive symptoms among Hispanic individuals. JAMA Otolaryngol Head Neck Surg 2019;145(2):132–139.
3Lin FR, Ferrucci L. Hearing loss and falls among older adults in the United States. Arch Intern Med 2012;172(4):369–371.
4Agmon M, Lavie L, Doumas M. The association between hearing loss, postural control, and mobility in older adults: A systematic review. J Am Acad Audiol 2017;28(6):575–588.
5Ray J, Popli G, Fell G. Association of cognition and age-related hearing impairment in the English Longitudinal Study of Ageing. JAMA Otolaryngol Head Neck Surg 2018;144(10):876–882.
6Lin FR, Ferrucci L, Metter EJ, An Y, Zonderman AB, Resnick SM. Hearing loss and cognition in the Baltimore Longitudinal Study of Aging. Neuropsychology 2011;25(6):763–770.
Hearing Testing Questions
It is clear from all current federal proposed rules that audiologists should be able to dispense OTC hearing aids. It is not clear whether given the other constraints on audiological practice imposed by states whether you, as an audiologist, will be required to provide a hearing test prior to dispensing OTC hearing aids. As the regulations evolve, be sure to verify your state regulations.
Requirements for hearing testing when an audiologist provides an OTC hearing aid are not clear at this time. Many of you will want to provide a diagnostic hearing evaluation as part of your services because it follows best practices in terms of creating a hearing-care plan. This also is true when the hearing-care plan includes OTC hearing aids.
This approach also would avoid potential reputational harm if individuals who are not candidates for OTC hearing aids purchase them from the practice. The proposed FDA rules do not require manufacturers to allow returns of OTC devices. Although manufacturer return policies for OTC hearing aids are not clear at this time, should this be an option from some manufacturers, audiologists may choose to dispense only OTC devices that can be returned. This would allow the practice, if they so choose, to offer a period during which the consumer can return the OTC hearing aid and apply the amount paid to a traditional (prescriptive) hearing aid fitting if the OTC hearing aid does not meet their needs. This answer will be updated as additional information about potential return policies for OTC devices becomes available.
The Academy has included FAQs for consumers that emphasize the wisdom of having a hearing test conducted by an audiologist prior to making any hearing-health decisions and the link to Find an Audiologist Directory is provided throughout the consumer information.
For more information, visit FAQs for Consumers Related to OTC Hearing Aids.
Yes. A hearing test can be required if you routinely require a hearing test in order to create a plan of treatment regardless of whether that plan includes a prescriptive fitting or an OTC hearing aid. Considering the proposed FDA rule, you cannot require a hearing test specifically to dispense an OTC hearing aid. An explanation to patients about the advantages of a hearing evaluation prior to any hearing aid fitting would be beneficial in this scenario. Should a patient decide to forego a hearing evaluation, documentation in the chart should clearly state that a hearing evaluation was recommended and declined. Each audiologist will need to monitor state laws that may dictate the need for a hearing test when an OTC hearing aid is dispensed by an audiologist. Currently, it is not clear where states stand on this issue.
Legal Issues
Working with OTC hearing aids does not require any type of license, registration, or specific training. The audiology assistant should be able to instruct patients in OTC hearing aid use and care. Be sure to check your state regulations as indicated.
As currently worded, the intention of the FDA proposed rule is that individual state regulations will not create barriers for consumers wishing to pursue OTC hearing aids. The Academy will be monitoring this information and encourages audiologists to monitor implementation within their states as the situation evolves.
The proposed FDA rule includes preemption to current state regulations related to hearing aid sales. The Academy will review the final rule, once released, to determine any impact on the provision of prescriptive hearing aids. The description below is what can be interpreted thus far from the FDA proposed rule.
The proposed rule preempts (invalidates) any state or local rule pertaining to the supervision, prescription, order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids (g)(1). This preemption does not translate to the regulation of audiologists but disallows audiologists and other hearing-health-care professionals from “interfering with or restricting commercial activity” related to OTC hearing aids.
General requirements that apply to any place of business that offers goods that are generally applicable would not be preempted. For example, if a state requires an OTC provider, such as a pharmacy, to include terms of sale or return on the receipt of any good, this will also apply to OTC hearing aids sold at that store (g)(2)(a). A state cannot, however, require a pharmacy or other store to obtain a license or certification to sell OTC hearing aids.
Per the proposed rule, states can apply to be exempt from preemption. To qualify, the proposed rule indicates that the exemption must be more stringent than the proposed rule (i). States that are currently exempt from preemption, or the process of applying for preemption, would need to re-apply once the rule is formalized. Such state exemptions include (i)(2):
- Medical device requirements that apply to hearing aids
- Conditions for sale
- Hearing aid labeling requirements
The proposed rule from the FDA does not require that OTC hearing aids be returnable. However, the FDA does require that package labeling state the return policy for a device.
Device Questions
This issue is not specifically addressed in the FDA proposed rule.
Since OTC hearing aids are not intended to require the involvement of a licensed hearing-health-care professional, it is assumed that the consumer has read the information provided about the product to inform a decision to purchase.
OTC hearing aids present an opportunity for you, as audiologists, to be a resource for patients (or potential patients). Practices may consider placing information on their website that provides general guidance about OTC hearing aids and offer appointments to patients who have purchased OTC hearing aids and require assistance.
The FDA proposed rules rely on an existing voluntary consensus standard for personal sound amplification products (ANSI/CTA 2051-2017: Personal Sound Amplification Performance Criteria) for the OTC hearing aid minimum requirements. Depending on the OTC hearing aid, an audiologist should be thoughtful about how to connect the device to the hearing aid analyzer coupler to make these measurements.
Perhaps more relevant to patient care, any device that produces sound can be measured using real-ear probe microphone measurements on the patient. If the goal is to determine whether the amplification is correct for the patient, the fitting can be approached similarly to that of a prescriptive hearing aid—convert HL thresholds to SPL thresholds using real-ear-to-coupler difference, generate evidence-based targets, and measure hearing aid output using real-ear aided response.
Various levels of speech are presented, and output is measured to compare against targets. Although flexibility of settings of OTC devices is not known at this time and will vary, if the OTC hearing aid is adjustable, the audiologist may be able to tune the device to better meet the patient’s hearing needs. Professional fees should be charged for these services.
This capability will depend on the manufacturer making and supplying the OTC hearing aid.
OTC hearing aids are intended to be “self-fitting” and to not require the involvement of a hearing-health-care professional. It is not known at this time whether OTC devices will be programmable and the amount of flexibility in adjustments that will be available. Some devices may come with controls that allow for adjustments to volume or other features, and some may be programmed by the user, including potentially with a smartphone app.
More Information and Support
Yes, the Academy will continue to provide and update information for members, allied health-care professionals, and consumers. See the Academy website for current information regarding OTC hearing aids.
Be sure to visit the Academy’s Consumer website. There you can review FAQs for Consumers related to OTC hearing aids and guidance to ensure that parents recognize that OTC hearing aids are not for children.
The Academy’s e-learning platform, www.eaudiology.org, currently has five OTC hearing aid web seminars available on demand and will be adding another session delivered at the AAA 2022+HearTECH Expo. Look forward to additional webinars and educational offerings focused on OTC hearing aids once the final FDA rule is released.
The most common hearing loss in adults comes on gradually. Individuals often do not identify the level of their hearing loss accurately because of these gradual changes over time. This makes it difficult for individuals to identify accurately if they are a candidate for over-the-counter hearing aids (someone with a mild-to-moderate hearing loss).
A hearing evaluation can help a consumer be confident that they are a candidate. You may want to promote your diagnostic services to assure individuals that they can receive an assessment and advice without purchasing a solution directly from your practice. Or you may want to let the public know that you will provide a plan of treatment that will include OTC hearing aids if they are appropriate for the individual. Alternatively, you may focus your efforts on individuals who are looking for customized solutions.
Language describing what the audiologist offers in terms of customization is provided below, and you may find this helpful in communicating with patients asking about why they should see an audiologist:
When you come to an audiologist thinking about getting hearing aids, the audiologist uses the information from the hearing test as well as information from an in-depth interview with you about your lifestyle, listening needs, and communication demands.
It may seem like picking a hearing aid is straightforward, but quite a bit of information must be collected to make the best choice for you.
The degree of hearing loss, ear-canal characteristics, and individual preferences will all impact the recommendation of style (what the hearing aid physically looks like). Your lifestyle and communication demands impact the technology and features that should be selected and how these are programmed in the hearing aid fitting.
Because of the gradual nature of the onset of adult hearing loss, your brain is tuned to listening through the hearing loss and considers that input “normal” even though sound is being filtered by the hearing loss. Because the brain thinks that is normal, it is difficult for you to judge how much amplification is needed when you try hearing aids.
People typically have different amounts of hearing loss at different pitches, which complicates this even more. Some people may hear low-pitched sounds fine, but cannot hear or understand high-pitched sounds. When an audiologist fits a hearing aid, they put a microphone in your ear canal to measure the output of the hearing aid at different presentation levels across different pitches to tune the hearing aid specifically to your individual ear canal and hearing loss. This ensures that sounds are at the correct level to be heard but not so loud that they can injure your hearing.
On the first day of the hearing aid fitting, most patients indicate that sounds do not seem normal to them and that is because the brain is not used to hearing many of these softer sounds. It may take several weeks of full-time use (all waking hours) to adjust to a new hearing aid fitting because the brain must adapt to this new normal. Without these measurements, it is impossible to know if the amplification device has been set optimally for you.
If you pursue an OTC hearing aid and do not feel that you are receiving the benefit you expected, you may want to schedule with an audiologist who can make these measurements in the ear canal and provide you with advice about how you might want to re-set the device if it has controls on it for fine-tuning. You would expect to pay an office visit fee for these services.
Remember that if you are exposed to loud sound over time, your hearing can be damaged. If you are concerned that your hearing has changed, you will want to see an audiologist for an updated hearing test.
Whereas hearing aids are intended to treat impaired hearing, personal sound amplification products (PSAPs) are meant for individuals with normal hearing who want to amplify sounds in certain situations, for example, bird watching. PSAPs are regulated as consumer electronics as opposed to medical devices, thus quality can vary widely. The FDA does not regulate PSAPs for safety and effectiveness as it does hearing aids. Individuals should be careful not to keep the device on if the sound is very loud—they could damage their hearing over time. PSAPs are usually low cost (less than $100.00) and simple to operate.
Hearables are worn in or on the ears (for example, headset, earbuds) and wirelessly receive a sound signal from another device (for example, phone, television). The headset may have a volume control or an app associated with it so the user can turn the volume up or down to meet their listening needs. Hearables provide situation-specific listening solutions (for example, phone, television) rather than a hearing solution for a listener’s entire day of communication. Some hearables allow the user to adjust the pitch or loudness of the sound. These devices also may provide biometric tracking (how many steps walked, heart rate, etc.). This type of wireless connectivity can be included in professionally fit hearing aids as well, but the hearing aids are also providing custom amplification to the signals being heard and are used throughout the day.
Hearables are not regulated by the FDA for safety and effectiveness. Individuals will want to be thoughtful about how loud they listen to sound. If users are concerned about the level of sound they are using, an audiologist can measure the output of a headset and inform if the user is in a safe listening range depending on how much time they spend listening at that level.
